Medical research involving human subjects is strictly controlled by the South African Health Products Regulatory Authority (SAHPRA); DOH and Ethics Committees.
It is mandated that the research team be well versed with the International (ICH) and SA Good Clinical Practice guidelines. Each member of the team must be in possession of a valid, accredited GCP certificate.
Medical research involving human subjects is strictly controlled by the South African Health Products Regulatory Authority (SAHPRA); DOH and Ethics Committees. It is mandated that the research team be well versed with the International (ICH) and SA Good Clinical Practice Guidelines. Each member of the team must be in possession of a valid, accredited GCP certificate.
This course is a revision of Good Clinical Practice principles and processes for all clinical trial personnel who have previously attended GCP training, incorporating current ICH and SA GCP Guidelines.
GCP Basic for Support Staff
GCP Refresher for Support Staff
Clinical Research Coordinator (Study Coordinator)
Clinical trials are research studies conducted with humans, aimed at evaluating a medical, surgical, or behavioural intervention. It is the primary way that researchers find out if a new treatment, like a new drug or diet or medical device is safe and effective in humans.
ABC of Quality Control
Running a clinical trial is a complex and detailed process. Maintaining accurate records and quality data throughout a clinical trial is a continual, dynamic process. Trial requirements are carefully prescribed in detailed documents such as the protocol, the ICH and SA GCP guidelines, data management plan and the project plan.
Business etiquette is the set of written and unwritten rules of conduct that make social interactions run more smoothly.
It is about building relationships with other people, by acting in an appropriate, respectful and considerate way in the workplace.
Through technology everyone in the workplace has become a writer and writing is a highly visible skill. Most organizations produce an increasing amount of written communication in the form of emails, reports, proposals and websites. Good business writing saves time and money. It prevents mistakes and helps solve problems. It bridges time zones and culture gaps, connecting people.
Effective communication is a basic requirement for the achievement of organizational goals. Where there is effective communication, people experience fewer misunderstandings, employee morale is better, strategy is clear to all and each person understands where they fit in.
Good customer service is important for any organisation. It determines the level of stakeholder satisfaction, how the organisation rates against competitors, likelihood of survival and what the public image is.
Internal customer service is often neglected. Good internal customer service improves employee morale, productivity, employee retention, external customer service and, ultimately organisational efficiency.
Emotional intelligence is one of the biggest predictors of performance in the workplace and a strong driver of leadership and personal excellence. It is the ability to identify and manage own emotions and recognise the emotions of others. It’s a critical factor in personal and professional success.
Introduction to Project Management
PMI defines project management as “the application of knowledge, skills, tools, and techniques to project activities to meet the project requirements.” Project management is an essential skill in most workplaces and projects often fail due to a lack of effective project management skills.
Presenting information clearly and effectively is a key skill to getting a message or opinion across.
The three objectives of an effective presentation are as follows:
To establish credibility with the audience
To communicate information clearly to the audience
To persuade and/or influence the audience
The three key elements for a successful presentation is effective use of design, clear content and structured planned delivery.
Problem solving requires two distinct types of mental skill, analytical and lateral thinking.
Analytical skills refer to the ability to assess a situation, seek multiple perspectives, gather more information if necessary, and identify key issues that need to be addressed .
Lateral thinking refers to the ability to solve problems through an indirect and creative approach, using reasoning that is not immediately obvious and involving ide-as that may not be obtainable by using traditional step by step logic.
Self-management refers to a combination of different behaviours that focus on how people manage themselves in their work and personal life.
There are a number of skills linked to effective self-management, such as taking responsibility, displaying initiative, remaining resilient, acting assertively, managing time optimally and being flexible.A good understanding of self is critical for identifying areas of focus and development.
Many people struggle with time management. There simply does not seem to be enough hours in a day to accomplish all the tasks that need to be completed. Effective use of time is very important.
Time management is the process of planning and controlling the amount of time spent on specific activities, especially with the goal of increasing efficiency and productivity.
Effective Performance Management
Performance Management is a key process in any organisation and should assist the management and staff to focus on the key issues and business objectives to ensure sustainability. Performance management means creating both competence and growth for employees.Effective performance management incorporates a series of on-going assessments, processes and activities that encourage growth and measure progress in attaining objectives. Good performance management focuses on developing others.
This course will help in assessing performance and making decisions to develop the performance of others.
Introduction to Labour Law
Managers don’t have to be experts in labour law, but should have a good working knowledge and understanding of labour law and the workplace policies in so far as it pertains to the daily management of staff and operations, including (but not limited) to the following;
Corrective action when needed to minimise misconduct in the workplace;
Implementing discipline in a fair, non-emotive, professional and consistent manner;
Managing employee performance (good or bad) to meet the objectives of the organisation and department.
Grant writing (coming soon)
Introduction to Grant management (coming soon)
Grant management refers to the processes and administration put in place to fulfil the requirements of a grant and meet the donor requirements.